Status:
WITHDRAWN
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
Lead Sponsor:
Alcon Research
Conditions:
Otitis Media
Eligibility:
All Genders
6-12 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympa...
Eligibility Criteria
Inclusion
- Requires bilateral myringotomy and tympanostomy tube insertion;
- Provides informed consent (parent/legal guardian);
- Signs assent form where applicable (subject);
- Accompanied by parent/legal guardian at each visit;
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Menarcheal females;
- Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;
- Use of excluded medications within one week prior to surgery and for the duration of the study;
- Requires another surgical procedure in addition to the myringotomy;
- Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;
- Participation in any other investigational study within 30 days before entry into this study or along with this study;
- Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01908764
Start Date
November 1 2014
End Date
January 1 2015
Last Update
March 8 2016
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